The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show.
Dr. Vinay Prasad, director of the agency’s Center for Biologics Evaluation and Research, said in two memos that he disagreed with reviewers’ conclusions about the vaccines’ safety and about the ongoing threat of the virus that causes Covid-19, particularly for young and healthy people.
Prasad’s decisions are in line with broader Trump administration efforts, under the leadership of US Health and Human Services Secretary Robert F. Kennedy Jr., to restrict availability of coronavirus vaccinations. Kennedy said in May that the shots will no longer be recommended for healthy children and pregnant people; the FDA said earlier that month that it would approve a new Covid-19 vaccine but only for older people and those in higher-risk groups.
In a memo that week, Prasad had rejected a recommendation from about 30 FDA scientists to approve that vaccine, Novavax’s Nuvaxovid, for people 12 and older. He cited limited data and “a diminishing risk” of severe Covid-19 infection and safety concerns.
He cited similar safety concerns in a May 30 document, entitled “override memo,” regarding wide recommended use of Moderna’s latest version of its mRNA vaccine, mNexspike. The company had applied for approval of the updated version in people 12 and older.
Prasad wrote that despite the totality of data submitted by Moderna, he was unable to conclude that the manufacturer had improved the shot’s safety or conclusively addressed concerns about risks of myocarditis, or heart inflammation, in teenage and young men.
Earlier that week, the FDA had advised Moderna and another maker of mRNA Covid-19 vaccines, Pfizer, to update their labels to include warnings about this rare condition.
“Novavax is focused on ensuring that vaccination for COVID-19 is available to those who are at highest risk and who choose to be vaccinated,” the company said in a statement Wednesday. “We believe it is important that consumers have choice in selecting the vaccine that is right for them.”
Moderna declined to comment for this story.
Experts see ‘major overreach’
Dr. Daniel Griffin, an infectious disease specialist at Columbia University, said the memos reflect wider talking points among health officials.
“They seem obsessed with myocarditis, and they made a decision on that which they just have a fixed ideology that they keep looking for confirmation bias on,” he said. “And the data there, I think, is really clear. Early on, we saw, let’s say, 20 to 65 [cases] per million doses when we were giving the initial [vaccine] doses three to four weeks apart. … We really, actually haven’t seen very much since it was spaced out. And what we have seen is that now everyone is getting Covid – it’s really kind of a question of how often per year – and the risk of ending up with myocarditis being unvaccinated is tenfold higher than if you’re protected by a vaccine. So their their argument of restricting access to the vaccines to protect us against myocarditis is flawed. They’re increasing our chance tenfold by restricting our access.”
The memos also mark a break from typical agency responsibilities, Griffin said.
“The role of the FDA is to make a decision based upon the safety and efficacy of a product, whether or not it should be licensed or not. But as far as restricting access, as far as providing guidance on who should specifically get a vaccination, that has fallen to the [US Centers for Disease Control and Prevention] and a number of professional societies for decades. So I think most of us would view this as a major overreach of the of the responsibility of the FDA. The FDA is is not supposed to have the power to restrict access to safe and effective products.”
Dr. Peter Marks, who was director of CBER before Prasad, said in a text message Wednesday that “In the past, the center Director override memos were rare and only done after very careful consideration – and usually after consultation with other center directors. During the nearly decade that I was at FDA, there were only a few that I authored – certainly less than one a year on average during my tenure at CBER – and that included all the various types of decisions that could be overridden.”
Dr. Peter Lurie, a former FDA associate commissioner who’s now president and executive director of the Center for Science in the Public Interest, said overrides like Prasad’s tend to err on the side of being less restrictive – making a product available when reviewers are more cautious. He’s never seen one restrict the use of a product that reviewers have deemed safe and effective.
“It’s very hard to escape the conclusion that antipathy towards these Covid vaccines is playing a significant role in this extremely rare override,” he said. “I think the concern remains that, yes, they were making policy decisions that should have been reserved for the CDC.”
Prasad’s memos were first reported by the New York Times.
Prasad questioned approval process
Prasad assumed his role as CBER director on May 8, a little over a month after Marks said he had been forced out of the role due to Kennedy’s vaccine strategy. More recently, FDA Commissioner Dr. Marty Makary also elevated Prasad to be the agency’s chief medical and scientific officer.
Prasad is a hematologist-oncologist and outspoken critic of what he’s argued as groupthink in medicine. The former University of California San Francisco professor became a prominent voice during the pandemic for challenging Covid-era mandates but has also questioned the drug approval process and developers’ reliance on secondary results, or surrogate endpoints, in clinical trials.
Prasad has called previous FDA commissioners — under both Democratic and Republican administrations — “pro-corporate, sell-outs” who have not required enough randomized clinical trial data in approval decisions.
Biotech stocks tumbled in the hours after his announcement as CBER director, with some industry analysts calling Prasad an “anti-establishment” pick to lead the department overseeing vaccines and biologic products.
He seemed to nod to those concerns in a May 20 town hall with Makary, suggesting a flexible approach that speeds up drug approvals.
“We have to, and we will, always embrace surrogate endpoints for people who have very concerning diseases, very rare conditions, few treatment options,” he told FDA staff at the agency’s Maryland campus. “We have an obligation at FDA to expedite those products to those patients who desperately want them. We also have an obligation to check on the back end and make sure that we’re actually achieving what we thought we were.”
Prasad also signaled his approach to Covid-19 vaccines during that town hall.
“The risk of severe disease and hospitalization, thank goodness, has fallen among the American people. The efficacy of repeat doses … of these vaccines to further reduce severe disease and symptomatic illness is uncertain, and there are important safety considerations whose long-term impact is not fully known,” he said. “We will continue to monitor those closely.”
